Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
NCT ID: NCT02178163
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1020 participants
INTERVENTIONAL
2014-08-01
2027-07-31
Brief Summary
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Detailed Description
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I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens.
SECONDARY OBJECTIVES:
I. To estimate the percentage of patients in whom genomic analysis can be performed.
II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results.
OUTLINE:
Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Ancillary-Correlative (comprehensive genomic analysis)
Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. Based on the results of the genomic analysis, patients may begin therapy.
cytology specimen collection procedure
Correlative studies
laboratory biomarker analysis
Correlative studies
Interventions
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cytology specimen collection procedure
Correlative studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Zubrod performance status 0-2
* Life expectancy \>= 3 months
* Absolute neutrophil count of \> 1.5 x 10\^9/L
* Platelet count \> 100,000 x 10\^9/L
* Serum creatinine =\< 1.5 times the institutional upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft-Gault formula) of \> 45 mL/min
* Serum bilirubin =\< 1.5 X ULN
* Transaminases (serum glutamic oxaloacetic transaminase \[SGOT\] and/or serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times institutional ULN and alkaline phosphatase =\< 2.5 times ULN, unless patient has liver metastases and the managing physician believes that the elevation in liver enzymes is only related to the liver metastases
* Laboratory tests should be done within 30 days of enrollment on the trial
* A biopsy of the patient's tumor for genomic profiling is required; this biopsy specimen can be an already obtained diagnostic specimen provided the patient has not received systemic therapy since the biopsy has been obtained and was obtained within 60 days of trial enrollment. The biopsy material cannot be from a tumor site that has been radiated.
* Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines
Exclusion Criteria
* Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible
* Pregnant or lactating women; female patients of child bearing potential will be informed that if they do enroll on a therapeutic trial, based on the genomic analyses, that they may not be able to enroll on a clinical trial if they are pregnant; all sexually active patients will be informed that patients enrolling on a therapeutic trial have to use contraceptive methods to prevent pregnancy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Gerold Bepler
Principal Investigator
Principal Investigators
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Gerold Bepler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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KCI at McLaren Bay Region
Bay City, Michigan, United States
KCI at Mclaren Bloomfield Hills
Bloomfield Hills, Michigan, United States
KCI At McLaren Clarkston
Clarkston, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
KCI at McLaren Flint
Flint, Michigan, United States
KCI at McLaren Greater Lansing, Mid Michigan Physicians
Lansing, Michigan, United States
KCI at McLaren Lapeer Region
Lapeer, Michigan, United States
KCI at McLaren Macomb
Mount Clemens, Michigan, United States
KCI at McLaren Central Michigan
Mount Pleasant, Michigan, United States
KCI at Northern Michigan
Petoskey, Michigan, United States
KCI at McLaren Port Huron
Port Huron, Michigan, United States
Countries
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Central Contacts
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Gerold Bepler, M.D.
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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NCI-2014-00913
Identifier Type: REGISTRY
Identifier Source: secondary_id
W81XWH-11-1-0500
Identifier Type: OTHER
Identifier Source: secondary_id
2014-002
Identifier Type: OTHER
Identifier Source: secondary_id
2014-002
Identifier Type: -
Identifier Source: org_study_id
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